Glifo-M XR 5 mg+1000 mg (Tablet (Extended Release))
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Medicine Details
| Category | Details |
|---|---|
| Generic | Empagliflozin metformin hydrochloride |
| Company | Acme laboratories ltd |
| Also available as |
Indications
- Treatment of adults with type 2 diabetes mellitus
- Adjunct to diet and exercise
- Insufficiently controlled on maximally tolerated dose of Metformin alone
- Combination therapy with other medicinal products for diabetes
- Patients treated with Empagliflozin and Metformin as separate tablets
Pharmacology
- Inhibition of Sodium-Glucose Co-Transporter 2 (SGLT2)
- Reduction of renal reabsorption of glucose
- Lowering of renal threshold for glucose
- Reduction of hepatic glucose production
- Improvement of insulin sensitivity
Dosage & Administration
- Individualization based on effectiveness and tolerability
- Twice daily intake with meals
- Gradual dose escalation to reduce gastrointestinal side effects
- Maximum recommended daily doses for Metformin and Empagliflozin
- Dosing adjustment for extended-release formulations
- Assessment of renal function before initiation
- Contraindication for patients with eGFR below 45 mL/min/1.73 m²
- No established safety and effectiveness for pediatric patients under 18 years
Interaction
- Potential interactions with diuretics
- Increased risk for hypoglycemia with insulin or insulin secretagogues
- Inadvisability of using urine glucose tests for monitoring
- Drugs that reduce Metformin clearance
- Risk of lactic acidosis with carbonic anhydrase inhibitors
- Effect of various drugs on glycemic control
- Potentiation of Metformin effect by alcohol intake
Contraindications
- Hypersensitivity to Empagliflozin and Metformin
- Acute metabolic acidosis
- Diabetic pre-coma
- Severe renal failure
- Acute conditions altering renal function
- Conditions causing tissue hypoxia
- Hepatic impairment
- Acute alcohol intoxication or alcoholism
Side Effects
- Urinary tract infection and genital mycotic infections
- Common adverse effects associated with Metformin
- Potential reactions including hypoglycemia and gastrointestinal symptoms
- Occurrence of uncommon and rare effects
Pregnancy & Lactation
- Advisement of potential risk to a fetus
- Discouragement from use during breastfeeding
Precautions & Warnings
- Risk of Metformin-associated lactic acidosis
- Necessity to assess and correct volume status before initiation
- Evaluation for signs and symptoms of hypotension
- Assessment for ketoacidosis
- Temporary discontinuation in settings of reduced oral intake or fluid losses
- Risk for urinary tract infections
- Consideration of lowering insulin dose to reduce hypoglycemia risk
- Potential lowering of vitamin B12 levels by Metformin
- Requirement for increased LDL-C monitoring
- Lack of established macrovascular risk reduction evidence
Overdose Effects
- Safety of single and multiple doses of Empagliflozin
- Potential occurrence of lactic acidosis with Metformin overdose
- Necessity for prompt treatment in case of overdose
- Effectiveness of haemodialysis in removing lactate and Metformin
Therapeutic Class
- Combination Oral hypoglycemic preparations
Storage Conditions
- Storage below 30°C
- Protection from light and moisture
- Keep out of reach of children